PENG vs Intra-articular Injection for Hip Arthroscopy (PARİAH)

Pericapsular Nerve Group (PENG) Block Versus Intra-articular Injection for Hip Arthroscopy: A Randomized Trial

Hip arthroscopy is a popular surgical method that is increasingly being used for both intraarticular and extraarticular hip surgeries. Postoperative acute pain is difficult to control in hip surgeries due to the complex nature of hip innervation and the large number of surgical interventions. Optimal treatment of postoperative pain in hip arthroscopy is very important to be able to perform rehabilitation, avoid opioid side effects and minimize unplanned re-hospitalization. Regional anesthesia techniques are widely used because of their proven efficacy in post-surgical pain management and their safety profile that ultimately contributes to early recovery. Many regional techniques such as neuraxial blocks, lumbar plexus block, femoral nerve block, fascia iliac block and intraarticular local anesthetic injection have been used for the treatment of acute postoperative pain.

Femoral nerve and fascia iliac blocks have shown good results for long-term post-surgery analgesia. However, the obturator nerve and accessory obturator nerve should be targeted to achieve more effective perioperative pain control. There are studies reporting that pericapsular nerve group block (PENG), which has been defined in recent years, provides effective perioperative analgesia in hip surgeries. In this study, we aim to compare the effectiveness of PENG block and intra-articular local anesthetic injection in hip arthroscopy.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Opioid Use
• Intervention / Treatment: Procedure: Intra-articular local anesthetic injection; Procedure: Pericapsular nerve group block

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serdar Yeşiltaş, Asist Prof.; Phone Number: 05423632630; Email: syesiltas@bezmialem.edu.tr
• Study Contact Backup: Name: Yeşiltaş, Asist Prof.

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Recruiting
    • Bezmialem Vakıf University
    • Contact: Serdar Yeşiltaş, Assist.Prof; Phone Number: 05423632630; Email: syesiltas@bezmialem.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Association of Anesthesiologists (ASA) physical status I - III
• BMI 20 to 35 kg / m2
• Patients scheduled for elective hip arthroscopy
• Able to provide informed consent.

Exclusion Criteria:

• Patients who refuse to participate in the study,
• Coagulopathy,
• Sepsis,
• Hepatic or renal insufficiency,
• Pregnancy
• Allergy to local anesthetic drugs,
• Chronic pain condition requiring opioid intake at home,
• BMI above 40.
• History of psychiatric diseases needing treatment.
• Failure of nerve block
• Substance abuse history
• Hip revision surgery
• Underlying neurologic disorder affecting pain perception.
• Angina, heart attack, heart failure
• Kidney or hepatic insufficiency
• Stroke
• Gastrintestinal bleeding history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided pericapsular nerve group block; Injection of 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml isotonic saline mixture between iliopubic eminentia and psoas tendon under ultrasound guidance	Procedure: Pericapsular nerve group block; PENG block will be made with 15 ml 0.5% bupivacaine + 2 mg dexamethasone + 14.5 ml NaCl under US-guidance
Active Comparator: Intra-articular local anesthetic injection; At the end of the surgical case, a total of 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml isotonic saline injection intra-articularly.	Procedure: Intra-articular local anesthetic injection; Intra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.	up to the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity score	Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0.5, 1, 3, 6, 12, 24 hours postoperatively.	0.5, 1, 3, 6, 12, 24 hours postoperatively.
First rescue analgesic time	The investigators will collect time to first rescue analgesic consumption in each group	up to the first 24 hours postoperatively
Postoperative nausea and vomiting	Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).	up to the first 24 hours postoperatively
Patient satisfaction	Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)	at the end of 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Yeşiltaş, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hip arthroscopy, intra-articular injection, PENG block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 71306642-050.05.04-

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No